Vastuskiri

Dear Alisa,

 

Thank you for your inquiry.

 

An authorised representative is defined in MDR as (32) any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation. So by definition an authorized representative needs to be appointed only when the manufacturer is registered in a country outside of EU. As you are asking about a Lithuanian manufacturer, an authorized representative is not required.

 

Would you like the account in EMDBB to be under your name? In this case I can make the account for you as I already have all the necessary data. If it needs to be under someone else’s name, we’ll need the person’s full name, e-mail address and the position in the company.

 

Sincerely Yours,

 

Janne Aule

Chief Specialist

Department of Medical Devices

+37258668664

[email protected]

 

Republic of Estonia Terviseamet/Health Board +372 794 3500 [email protected] www.terviseamet.ee Paldiski mnt 81, 10614 Tallinn Estonia

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From: Alisa IPB <[email protected]>
Sent: teisipäev, 7. mai 2024 08:16
To: Meditsiiniseadmed (Medical Devices) <[email protected]>
Cc: Aida Binkauskienė <[email protected]>; Natalija Mikalajūnė <[email protected]>
Subject: distribution of medical devices, manufactured in the EU, in Estonia

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

 

Dear Sir or Madam,

 

We, Innovative Pharma Baltics, the company based and manufacturing MDs in Lithuania, wish to distribute these MDs, class I, in Estonia.

 

We have got acquainted with the regulations required for MD in Estonia, including, but not limited to:

Q&A conformity documents - final_2020-05-18 (europa.eu), §26 (4) of MDA,  MDA §16, 

EU regulation 2017/745 (MDR), Estonian Medical Devices Act (MDA) and Estonian Language Act (LA),

Guide EMDDB.pdf.

 

The only few questions we have for today are:

 

1) Does Lithuanian manufacturing company need an authorised representative in Estonia?

2) If the authorised representative is not needed for the MDs manufactured in the EU, then please provide us the access to the EMDDB

so we could complete the Notification procedure through EMDBB.

 

Many thanks for your collaboration,

 

Best regards,

 

--

Alisa Palaveniene Farmacijos skyriaus vedėja | Head of Pharma Department UAB Innovative Pharma Baltics Mokslininkų g. 6a Vilnius, Lietuva Tel.: +37064500270 El. p.: alisa@innovative.lt www.innovative.lt